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GMP Regulation Handbook: Pharmaceutical Development, ICH Q8(R2)
Guidance for Industry, Pharmaceutical Development Q8(R2)
U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER)
The ICH Q8R2 regulation handbook is used in association with several ISPE training courses:
- Biotechnology Manufacturing Facility Design Training Course (T31)
- Process Validation in Biotechnology Manufacturing (T32)
- Commissioning and Qualification Training Course (T40)
- Quality Risk Management Workshop (T42)
- Turning QbD into a Practical Reality Training Course (T43)
- Process Validation Training Course (T46)
Emerging Economy Publication Discount
ISPE members located in nations with emerging economies* are eligible for a 50% discount on publications from the regular member price. To receive the discount, members must be logged in with their ISPE member account. Contact Member Services at ask@ispe.org for more information or if you have questions about your membership status or this discount program. Discounts do not apply to Techstreet document downloads.
*Based on the World Bank's system for classifying national economies by GNI per capita. Includes low-income, lower middle-income, and upper middle-income economies. To learn more about the World Bank classification system, please click here. Currently includes the following nations, except where international sanctions apply:
- Afghanistan
- Albania
- Algeria
- Angola
- Argentina
- Armenia
- Azerbaijan
- Bangladesh
- Belarus
- Belize
- Benin
- Bhutan
- Bolivia
- Bosnia and Herzegovina
- Botswana
- Brazil
- Bulgaria
- Burkina Faso
- Burundi
- Cabo Verde
- Cambodia
- Cameroon
- Central African Republic
- Chad
- China
- Colombia
- Comoros
- Congo, Dem. Rep.
- Congo, Rep.
- Costa Rica
- Côte d’Ivoire
- Cuba
- Djibouti
- Dominica
- Dominican Republic
- Ecuador
- Egypt, Arab Rep.
- El Salvador
- Equatorial Guinea
- Eritrea
- Eswatini
- Ethiopia
- Fiji
- Gabon
- Gambia, The
- Georgia
- Ghana
- Grenada
- Guatemala
- Guinea
- Guinea-Bissau
- Haiti
- Honduras
- India
- Indonesia
- Iran, Islamic Rep.
- Iraq
- Jamaica
- Jordan
- Kazakhstan
- Kenya
- Kiribati
- Korea, Dem. People's Rep.
- Kosovo
- Kyrgyz Republic
- Lao PDR
- Lebanon
- Lesotho
- Liberia
- Libya
- Madagascar
- Malawi
- Malaysia
- Maldives
- Mali
- Marshall Islands
- Mauritania
- Mauritius
- Mexico
- Micronesia, Fed. Sts.
- Moldova
- Mongolia
- Montenegro
- Morocco
- Mozambique
- Myanmar
- Namibia
- Nepal
- Nicaragua
- Niger
- Nigeria
- North Macedonia
- Pakistan
- Palau
- Papua New Guinea
- Paraguay
- Peru
- Philippines
- Russian Federation
- Rwanda
- Samoa
- São Tomé and Príncipe
- Senegal
- Serbia
- Sierra Leone
- Solomon Islands
- Somalia
- South Africa
- South Sudan
- Sri Lanka
- St. Lucia
- St. Vincent and the Grenadines
- Sudan
- Suriname
- Syrian Arab Republic
- Tajikistan
- Tanzania
- Thailand
- Timor-Leste
- Togo
- Tonga
- Tunisia
- Türkiye
- Turkmenistan
- Tuvalu
- Uganda
- Ukraine
- Uzbekistan
- Vanuatu
- Vietnam
- West Bank and Gaza
- Yemen, Rep.
- Zambia
- Zimbabwe